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N Engl J Med. 1992 Feb 20;326(8):507-12.

A randomized trial of prednisolone in patients with severe alcoholic hepatitis.

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1
Service d'Hépatologie, Hôpital Beaujon, Clichy, France.

Abstract

BACKGROUND:

Controlled trials have yielded inconsistent results with regard to the efficacy of corticosteroids in the treatment of alcoholic hepatitis. Three meta-analyses suggest that they may be effective in patients with encephalopathy who have severe liver disease.

METHODS:

We conducted a randomized, double-blind trial comparing 28 days of prednisolone treatment (40 mg per day) with placebo in 61 patients with biopsy-proved alcoholic hepatitis and either spontaneous hepatic encephalopathy (n = 19) or a discriminant-function value higher than 32. The discriminant function used was as follows: 4.6 (prothrombin time-control time [in seconds]) + serum bilirubin (in micromoles per liter)/17. Fifty-seven of the patients had evidence of cirrhosis on biopsy. The primary end point was death within two months.

RESULTS:

One patient was lost to follow-up after 56 days. Treatment was discontinued in two patients because of drug toxicity. By the 66th day after randomization, 16 of 29 placebo recipients had died (mean [+/- SE] survival, 45 +/- 8 percent), as compared with 4 of 32 prednisolone recipients (survival, 88 +/- 5 percent) (log-rank test, 10.9; P = 0.001). The survival advantage for prednisolone persisted after stratification according to center and the presence of encephalopathy, and after adjustment for prognostic factors in a proportional-hazards model.

CONCLUSIONS:

Treatment with prednisolone improves the short-term survival of patients with severe biopsy-proved alcoholic hepatitis.

PMID:
1531090
DOI:
10.1056/NEJM199202203260802
[Indexed for MEDLINE]
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